National foreword

This British Standard is the UK implementation of EN ISO 16409:2016. It supersedes BS EN ISO 16409:2006+A1:2010 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/106/7, Oral hygiene products.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.

This European Standard was approved by CEN on 14 August 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thisEuropean Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical referencesconcerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENmember.

This European Standard exists in three official versions (English, French, German). A version in any other language made bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom.

European foreword

This document (EN ISO 16409:2016) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be withdrawn at the latest by May 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 16409:2006.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 16409:2016 has been approved by CEN as EN ISO 16409:2016 without any modification.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.

The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.

This second edition cancels and replaces the first edition (ISO 16409:2006), which has been technically revised with the following changes:

addition of bigger brush size 8 in Table 1;
specification of number of test samples (eight manual interdental brushes) in Clause 6;
clarification of measuring procedure for the passage hole diameter for cylindrical and tapered brush heads.
It also incorporates the Amendment ISO 16409:2006/Amd 1:2010.

Introduction

Manual interdental brushes are used for oral hygiene purposes intended to provide health benefits. Their main application purpose is mechanical plaque removal, primarily from the interdental regions.

1 Scope

This International Standard specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer’s instructions for use and labelling of the packaging.

Excluded are interdental brushes with a plastic core.

This International Standard is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.

2 Normative references

3 Terms and definitions

4 Classification

5 Requirements

5.1 Defects or contamination

5.2 Brush size

5.3 Filament retention

5.4 Stem retention

5.5 Stem durability

6 Sampling

7 Test methods

7.1 General

7.2 Pass/fail criteria

7.3 Visual inspection

7.4 Passage hole diameter

7.5 Filament retention

7.6 Stem retention

7.7 Stem durability

8 Test report

9 Accompanying information

9.1 Manufacturer’s instructions for use

9.2 Labelling on the package

10 Packaging

BS EN ISO 16409:2016

Dentistry. Oral care products. Manual interdental brushes

Current

Published:

31 Dec 2016